Onivyde

Common name: Irinotecan liposome injection

Trade name: Onivyde

All names: Irinotecan liposome injection, Onivyde, irinotecan liposome

Indications:

ONIVYDE is a topoisomerase inhibitor in combination with fluorouracil and leucovorin for the treatment of patients with pancreatic metastatic adenocarcinoma whose disease has progressed after gemcitabine-based therapy.

Dosage:

Do not use ONIVYDE as a substitute for other drugs containing irinotecan hydrochloride.

The recommended dose of ONIVYDE is 70 mg/m2 as an intravenous infusion over 90 minutes every two weeks.

For patients homozygous for UGT1A1*28, the recommended starting dose of ONIVYDE is 50 mg/m2 every two weeks.

There is no recommended dose of ONIVYDE for patients with serum bilirubin above the upper limit of normal.

Use corticosteroids and antiemetics for prophylaxis. 30 minutes before ONIVYDE.

Adverse Reactions:

Most common adverse reactions (≥20%) ONIVYDE: diarrhea, fatigue/weakness, vomiting, nausea, decreased appetite, stomatitis, and pyrexia. The most common laboratory abnormalities (≥3% grade 3 or 4) were lymphopenia and neutropenia.

Contraindications:

Severe hypersensitivity reaction to ONIVYDE or irinotecan hydrochloride.

Precautions:

Interstitial Lung Disease (ILD): Fatal ILD has occurred in patients receiving irinotecan HCl. If ILD is diagnosed, stop ONIVYDE.

Severe Hypersensitivity Reaction: Permanently discontinue ONIVYDE in case of severe hypersensitivity reaction.

Embryo-fetal toxicity: Can cause fetal harm. Inform women of the potential risk to the fetus and to use effective contraception.

Storage:

Store ONIVYDE at 2ºC to 8ºC (36°F to 46°F). Do not freeze. Avoid light.

Mechanism of action:

Irinotecan liposome injection is a topoisomerase 1 inhibitor encapsulated in lipid bilayer vesicles or liposomes. Topoisomerase 1 relieves torsional strain in DNA by inducing single-strand breaks. Irinotecan and its active metabolite SN-38 reversibly bind to the isomerase 1-DNA complex and prevent the religation of single-strand breaks, leading to exposure time-dependent double-stranded DNA damage and cell death. In mice bearing tumor xenografts, irinotecan liposomes administered at an irinotecan HCl equivalent dose 5-fold lower than irinotecan HCl achieved similar intratumoral exposure of SN-38.

Safety and efficacy:

For first-line treatment of pancreatic cancer, irinotecan liposome injection (Onivyde) plus chemotherapy (5-FU/LV+OX) has strong efficacy: the best overall response rate is 81.4%!

In July 2020, positive results of a phase I/II study in pancreatic cancer were announced at the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Oncology (WCGI).

The efficacy results showed that the median progression-free survival was 9.2 months and the median overall survival was 12.6 months. The best overall response rate included: 1 case of complete remission, accounting for 3%; 10 cases of partial remission, accounting for 31.3%; and 15 cases of stable disease, accounting for 46.9%. The best overall response rate was 81.4%. At week 16, 71.9% of study patients achieved disease control.